NCT00458107已完成1 期
An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SCA-136 Administered Orally to Healthy Japanese and Non-Japanese Female Subjects
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2007年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Adverse events, safety laboratories results, vital signs, and ECGs will be used to monitor subject safety.
研究概览
简要总结
This study is being conducted to evaluate the safety and tolerability of ascending multiple oral doses of SCA-136 adminstered to healthy Japanese and non-Japanese female subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese women or non-Japanese of child bearing potential using nonhormonal contraceptives.
- •Japanese female subjects are defined as being born in Japan but living outside of Japan for less than 5 years.
排除标准
- •Any significant disease.
- •Positive urine drug screen, increased liver funtion tests, use of prescription drugs.
结局指标
主要结局
Adverse events, safety laboratories results, vital signs, and ECGs will be used to monitor subject safety.
次要结局
未报告次要终点
研究者
研究点 (1)
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